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INVISALIGN SYSTEM - Indonesia BPOM Medical Device Registration

INVISALIGN SYSTEM is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20604024359. The device is manufactured by ALIGNTECH DE MEXICO S, DE R.L. DE C.V from Mexico, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is FONDACO JAYATAMA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : B
INVISALIGN SYSTEM
Analysis ID: AKL 20604024359

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Mexico

Authorized Representative

FONDACO JAYATAMA

AR Address

Pusat Niaga Roxy Mas Blok C4 No. 1-2 Jl. KH Hasyim Ashari Jakarta 10150

Registration Date

Aug 04, 2020

Expiry Date

Apr 21, 2025

Product Type

Therapeutic Dental Equipment

Orthodontic plastic bracket.

Non Electromedic Non Sterile

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